Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-11 @ 11:43 PM
Study NCT ID:
NCT00492960
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2007-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525167', 'term': 'larazotide acetate'}, {'id': 'D005983', 'term': 'Glutens'}], 'ancestors': [{'id': 'D055315', 'term': 'Prolamins'}, {'id': 'D000078522', 'term': 'Grain Proteins'}, {'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D055314', 'term': 'Seed Storage Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, placebo Controlled, dose ranging, multicenter Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2010-08-30', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-15', 'studyFirstSubmitDate': '2007-06-25', 'dispFirstSubmitQcDate': '2017-09-15', 'studyFirstSubmitQcDate': '2007-06-25', 'dispFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.', 'timeFrame': 'Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.', 'description': 'The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten'}], 'secondaryOutcomes': [{'measure': 'Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals', 'timeFrame': 'Up to 6 weeks', 'description': 'Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results'}, {'measure': 'To prospectively validate a composite, weighted index of celiac disease activity', 'timeFrame': 'GSRS was completed weekly throughout the study.', 'description': 'Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['larazotide acetate'], 'conditions': ['Celiac Disease']}, 'referencesModule': {'references': [{'pmid': '23163616', 'type': 'RESULT', 'citation': 'Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.', 'detailedDescription': 'This was a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter Study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months\n* Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.\n* BMI between 18.5 and 38, inclusive.\n\nExclusion Criteria\n\n* Has chronic active GI disease other than celiac disease\n* Has diabetes (Type 1 or Type 2).\n* Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.\n* Has hemoglobin value below 8.5 g/dL'}, 'identificationModule': {'nctId': 'NCT00492960', 'briefTitle': 'Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease', 'organization': {'class': 'INDUSTRY', 'fullName': '9 Meters Biopharma, Inc.'}, 'officialTitle': 'A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge', 'orgStudyIdInfo': {'id': 'CLIN1001-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Larazotide acetate 1 mg', 'description': 'larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks', 'interventionNames': ['Drug: larazotide acetate', 'Dietary Supplement: 900 mg gluten']}, {'type': 'EXPERIMENTAL', 'label': 'Larazotide acetate 4 mg', 'description': 'larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks', 'interventionNames': ['Drug: larazotide acetate', 'Dietary Supplement: 900 mg gluten']}, {'type': 'EXPERIMENTAL', 'label': 'Larazotide acetate 8 mg', 'description': 'larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks', 'interventionNames': ['Drug: larazotide acetate', 'Dietary Supplement: 900 mg gluten']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo capsules TID + 900 mg gluten capsules TID for 6 weeks', 'interventionNames': ['Drug: placebo', 'Dietary Supplement: 900 mg gluten']}], 'interventions': [{'name': 'larazotide acetate', 'type': 'DRUG', 'otherNames': ['AT-1001', 'INN-202'], 'description': 'gelatin capsules', 'armGroupLabels': ['Larazotide acetate 1 mg', 'Larazotide acetate 4 mg', 'Larazotide acetate 8 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'gelatin capsules', 'armGroupLabels': ['Placebo']}, {'name': '900 mg gluten', 'type': 'DIETARY_SUPPLEMENT', 'description': 'gelatin capsules', 'armGroupLabels': ['Larazotide acetate 1 mg', 'Larazotide acetate 4 mg', 'Larazotide acetate 8 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15243', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Study Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Study Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'city': 'Calgary', 'country': 'Canada', 'facility': 'Study Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Study Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'Study Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Winnipeg', 'country': 'Canada', 'facility': 'Study Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Francisco Leon, MD, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alba Therapeutics Corp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '9 Meters Biopharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}